Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

NCT ID: NCT01823237

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2024-02-29

Brief Summary

Dystonia is a disease where muscles in the affected body part are abnormally active. This may result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism is located in the motor area of the brain that controls the coordination of muscles, called the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite side of the body. When people perform tasks such as picking up an object or writing there are mechanisms in motor cortex that focus the level of activity so that they can do these tasks with a high level of precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When applied to the motor cortex it can upregulate or down regulate its activity. In the present study the investigators will conduct experiments on subjects with task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The investigators will assess the effects of this intervention using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.

Conditions

Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

rTMS

rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

rTMS sham

Placebo condition will use a sham coil and apply a very small magnetic stimulus

Group Type: PLACEBO_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Interventions

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Other Intervention Names

TMS

Eligibility Criteria

Inclusion Criteria

• If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
• Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
• No dystonic movements at rest
• Normal MRI scan of the brain as per clinical record
• No intake of CNS active drugs that may interfere with the study
• No contraindication for TMS
• Ability to perform the selective task
• No other neurological disease that may interfere with the study
• Ability to give informed consent

Exclusion Criteria

• You have a history of migraines
• You have a diagnosed seizure disorder
• You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
• You have any clips or implants in your head
• You have a pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Cathrin Buetefisch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cathrin Buetefisch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

DYST

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00062538

Identifier Type: -

Identifier Source: org_study_id